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10.1001/jama.2021.9508

http://scihub22266oqcxt.onion/10.1001/jama.2021.9508
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34283183!8293025!34283183
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suck abstract from ncbi


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pmid34283183      JAMA 2021 ; 326 (3): 230-239
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  • Effect of Canakinumab vs Placebo on Survival Without Invasive Mechanical Ventilation in Patients Hospitalized With Severe COVID-19: A Randomized Clinical Trial #MMPMID34283183
  • Caricchio R; Abbate A; Gordeev I; Meng J; Hsue PY; Neogi T; Arduino R; Fomina D; Bogdanov R; Stepanenko T; Ruiz-Seco P; Gonzalez-Garcia A; Chen Y; Li Y; Whelan S; Noviello S
  • JAMA 2021[Jul]; 326 (3): 230-239 PMID34283183show ga
  • IMPORTANCE: Effective treatments for patients with severe COVID-19 are needed. OBJECTIVE: To evaluate the efficacy of canakinumab, an anti-interleukin-1beta antibody, in patients hospitalized with severe COVID-19. DESIGN, SETTING, AND PARTICIPANTS: This randomized, double-blind, placebo-controlled phase 3 trial was conducted at 39 hospitals in Europe and the United States. A total of 454 hospitalized patients with COVID-19 pneumonia, hypoxia (not requiring invasive mechanical ventilation [IMV]), and systemic hyperinflammation defined by increased blood concentrations of C-reactive protein or ferritin were enrolled between April 30 and August 17, 2020, with the last assessment of the primary end point on September 22, 2020. INTERVENTION: Patients were randomly assigned 1:1 to receive a single intravenous infusion of canakinumab (450 mg for body weight of 40-<60 kg, 600 mg for 60-80 kg, and 750 mg for >80 kg; n = 227) or placebo (n = 227). MAIN OUTCOMES AND MEASURES: The primary outcome was survival without IMV from day 3 to day 29. Secondary outcomes were COVID-19-related mortality, measurements of biomarkers of systemic hyperinflammation, and safety evaluations. RESULTS: Among 454 patients who were randomized (median age, 59 years; 187 women [41.2%]), 417 (91.9%) completed day 29 of the trial. Between days 3 and 29, 198 of 223 patients (88.8%) survived without requiring IMV in the canakinumab group and 191 of 223 (85.7%) in the placebo group, with a rate difference of 3.1% (95% CI, -3.1% to 9.3%) and an odds ratio of 1.39 (95% CI, 0.76 to 2.54; P = .29). COVID-19-related mortality occurred in 11 of 223 patients (4.9%) in the canakinumab group vs 16 of 222 (7.2%) in the placebo group, with a rate difference of -2.3% (95% CI, -6.7% to 2.2%) and an odds ratio of 0.67 (95% CI, 0.30 to 1.50). Serious adverse events were observed in 36 of 225 patients (16%) treated with canakinumab vs 46 of 223 (20.6%) who received placebo. CONCLUSIONS AND RELEVANCE: Among patients hospitalized with severe COVID-19, treatment with canakinumab, compared with placebo, did not significantly increase the likelihood of survival without IMV at day 29. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04362813.
  • |*COVID-19 Drug Treatment[MESH]
  • |Aged[MESH]
  • |Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use[MESH]
  • |C-Reactive Protein/analysis[MESH]
  • |COVID-19/mortality/therapy[MESH]
  • |Combined Modality Therapy[MESH]
  • |Double-Blind Method[MESH]
  • |Female[MESH]
  • |Ferritins/blood[MESH]
  • |Fibrin Fibrinogen Degradation Products/analysis[MESH]
  • |Hospitalization[MESH]
  • |Humans[MESH]
  • |Interleukin-1beta/*antagonists & inhibitors[MESH]
  • |Kaplan-Meier Estimate[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Respiration, Artificial/*statistics & numerical data[MESH]
  • |Survival Rate[MESH]


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